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Judge Strikes Down FDA Off-Label Rules

Judge Strikes Down FDA Off-Label Rules

September 01, 1998

WASHINGTON--A federal judge has ruled that FDA regulations governing
the dissemination of research data supporting the off-label uses of
approved drugs and medical devices violate the First Amendments
guarantee of freedom of speech.

US district judge Royce C. Lamberth invalidated three FDA policy
documents regulating the distribution of reprints from scientific
journals and medical texts. In his decision, the jurist noted that
off-label use is common and that many physicians "consider
off-label use to constitute the standard of good medical care"
in some diseases.

The FDA, after reviewing the 58-page opinion and consulting with the
Justice Department, filed a motion asking Judge Lamberth to clarify
several points in his decision and to stay his order that the FDA
publish the ruling in the Federal Register until the clarifications
are made. Specifically, the agency asked whether the injunction
applies only to the three FDA guidance documents at issue and only to
unapproved uses of products that have been approved for other uses,
or extends to unapproved products as well.

Judge Lamberths ruling did not directly address changes in FDA
guidelines dictated by the FDA Modernization Act of 1997 because the
law does not become effective until this fall. FDA is currently
evaluating public comments on its proposed regulations to implement
the Act.

First Amendment Expanded

The suit against the FDA was brought by the Washington Legal
Foundation (WLF), which has pursued a number of legal actions against
federal regulators on the grounds that their rules constitute undue
interference in the affairs of individuals and businesses. In
pressing its lawsuits, the foundation draws on a 1978 Supreme Court
decision that made clear that "commercial speech" is also
covered by the First Amendment.

Richard A. Samp, WLFs chief counsel, said that "many
federal agencies adopted rules limiting speech long before 1978, and
it has taken many of them, FDA included, a number of years to realize
the implications of the expansion of the First Amendment to cover
commercial speech. The decision by Judge Lamberth, Mr. Samp said,
"places FDA squarely under the limitations of the First
Amendment. The FDA tried to argue that they werent limiting
speech; all they were doing was limiting conduct. The court gave
short shrift to that argument."

Judge Lamberth wrote: "In asserting that any and all claims
about the safety, effectiveness, contraindications, side effects, and
the like regarding prescription drugs are presumptively untruthful or
misleading until FDA has had the opportunity to evaluate them, the
FDA exaggerates its overall place in the universe."

In his opinion, the judge acknowledged a strong FDA interest in
encouraging companies to seek supplemental approval for recognized
off-label uses of their products and that the restrictions imposed by
the FDA advance that goal. But in striking down the FDA regulations,
Judge Lamberth ruled that the agency had restricted truthful speech
more extensively than necessary. His decision, however, upheld the
agencys power to regulate and suppress false and misleading
claims and to require that companies that do circulate information
include a disclaimer making clear that the FDA has not approved the
off-label use described.

Mr. Samp suggested that the courts decision will not have a
huge immediate impact. "What we asked for was fairly
limited," he said. "We wanted to limit what was
disseminated only to information that was indisputably true."

Three FDA Documents

Judge Lamberths ruling applies to three FDA documents: the Dec.
3, 1997 "Final Guidelines" on financial support provided by
manufacturers for continuing medical education; the Oct. 8, 1996
"Guidance" covering dissemination of materials from medical
texts; and the "Guidance" issued the same day covering
distribution of journal reprints.

The FDA Modernization Act requires the FDA to redraw its regulations
regarding the dissemination of information about off-label uses of
medications and medical devices. The agency issued its proposed new
rules in June.

With these rules, no longer would manufacturers have to wait until
FDA approved their supplemental applications before they could
provide "reliable and balanced" information to groups that
include physicians, pharmacy benefit managers, insurers, and group
health plans. But companies would have to certify they would file a
supplemental application or receive an exemption on grounds that the
needed studies were unethical or economically prohibitive.

The off-label information distributed would be only for drugs already
approved; be an unabridged copy of a peer-reviewed article or
reference publication; be neither false nor misleading; make certain
disclosures, including the fact that FDA has not approved the off-label
use, and provide the approved official labeling.

Judge Lamberths decision could force FDA to revise its proposed
rules. If not, it is "conceivable" that the WLF will once
again sue the agency, Mr. Samp said. The foundation strongly
criticized provisions in the anticipated off-label regulations.

"We thought FDA was using its regulations to gut the
Modernization Act," Mr. Samp said, citing the supplemental
applications exemption provision. Under the Act, a company could
still disseminate off-label information if it could show that seeking
supplemental approval for an off-label use was not economically
feasible, he said. "FDA has through its [proposed] regulations
defined that exemption out of existence. They have made it clear that
they will rarely if ever approve such an application."

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